Last updated: February 23, 2026
What is NDC 61755-0021?
NDC 61755-0021 refers to Evolocumab (Repatha), a PCSK9 inhibitor indicated to lower low-density lipoprotein cholesterol (LDL-C) in adults. It is administered via subcutaneous injection. This drug competes in the hypercholesterolemia treatment market, largely dominated by biologics.
Market Overview
Therapeutic Landscape
- Primary market: Hypercholesterolemia, a condition requiring LDL-C lowering drugs, especially for statin-intolerant patients or those needing additional LDL reduction.
- Market size (2022): The global hypercholesterolemia market was valued at approximately $22 billion.
- Key competitors: Alirocumab (Praluent), Evolocumab (Repatha), inclisiran, statins, ezetimibe.
Usage Patterns
- Under patent until at least 2030.
- Prescribed predominantly for familial hypercholesterolemia, inability to tolerate statins, or high-risk cardiovascular disease.
- Repatha's dosing: 140 mg every 2 weeks or 420 mg monthly.
Market Penetration
- Estimated to be used in approximately 2 million patients worldwide by 2022.
- Penetration mainly in the US, supported by payer coverage and clinical guidelines endorsing PCSK9 inhibitors for high-risk patients.
Price Analysis
Current Pricing
- List price: Approximately $14,100 annually per patient (per 420 mg monthly dose).
- Average net price: Estimated to be $8,000–$10,000 annually, after rebates and discounts.
- Reimbursement dynamics: Payers restrict use via prior authorization, influencing net revenues.
Pricing by Region
| Region |
List Price (Annual) |
Estimated Net Price |
Notes |
| United States |
$14,100 |
$8,500–$10,000 |
Significant payer negotiations and rebates |
| Europe |
€8,000–€10,000 |
€5,000–€7,000 |
Pricing varies by country, majority under negotiation |
| Rest of World |
$6,000–$8,000 |
$3,000–$6,000 |
Generally lower due to pricing controls |
Price Projections (Next 5 Years)
Assumptions
- Continued patent exclusivity until at least 2030.
- Market growth driven by increased diagnosis and guidelines expansion.
- Price erosion due to biosimilar competition unlikely before patent expiry.
- Payer negotiations keep net prices stable or slightly decreasing.
- Volume increases as awareness grows.
Projected Trends
| Year |
Price Range (Annual) |
Rationale |
| 2023 |
$13,500–$14,000 |
Stable list prices; ongoing payer negotiations |
| 2024 |
$13,000–$13,500 |
Slight cost-control measures, mild price erosion |
| 2025 |
$12,500–$13,000 |
Market saturation; early biosimilar entries unlikely |
| 2026 |
$12,000–$12,500 |
Extended payer discounts, volume increases |
| 2027 |
$11,500–$12,000 |
Further negotiations, potential discounts |
Market Dynamics Impacting Price
- Biosimilar Entry: No biosimilar approval or market entry is expected within the next 2–3 years.
- Patent Expiry: Scheduled around 2030, likely leading to significant price decreases.
- Regulatory Changes: Potential for price regulation or negotiation reforms, especially in Europe and Asia.
- Market Uptake: Increasing adoption enhances revenue stability but could pressure prices downward over time.
Summary
- Current price: Approximately $14,100 list price (annual).
- Net revenue: Estimated at $8,000–$10,000, influenced by rebates and negotiations.
- Forecast: Slight decline in net prices over the next five years, stabilizing before patent expiry.
- Market drivers: Growing patient awareness, expanding clinical guidelines, and increasing cardiovascular risk management.
Key Takeaways
- NDC 61755-0021 (Repatha) remains a high-value biologic, with steady demand and limited near-term price erosion.
- Significant potential for price declines is tied to patent expiration and biosimilar development around 2030.
- Payer negotiations heavily influence real-world net pricing.
- Market growth hinges on increased diagnosis, approval expansion, and adherence.
FAQs
1. Will the price of Repatha decrease before patent expiry?
Current trends suggest minor reductions primarily due to payer negotiations, but significant price drops are unlikely before patent expiration, scheduled around 2030.
2. How does biosimilar competition affect pricing?
Biosimilars could substantially lower prices post-patent, but none are expected to launch before 2030 due to regulatory and patent barriers.
3. What factors influence Repatha's market penetration?
Clinical guidelines endorse PCSK9 inhibitors for high-risk patients, payer reimbursement policies, and physician acceptance drive adoption.
4. Is Repatha's market growing?
Yes, driven by increasing awareness and treatment guidelines expanding indication coverage, especially for familial hypercholesterolemia and statin intolerance.
5. How do regional differences impact pricing?
European and other international markets typically see lower prices due to government negotiations and regulation, compared to US list prices.
References
- MarketWatch. (2022). Hypercholesterolemia Market Size & Forecast.
- IQVIA. (2022). Global Sales Data for PCSK9 Inhibitors.
- FDA. (2021). Repatha (Evolocumab) Labeling.
- EvaluatePharma. (2022). Biologics Patent Expiry Calendar.
- CMS. (2022). Reimbursement Policies for Biologics.
